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Medical Regulatory Affairs Specialist
hace 3 semanas
We are seeking a highly skilled Medical Writer to join our team of development, strategy, and scientific writing experts.
The ideal candidate will have a strong background in regulatory affairs and excellent client-oriented communication skills.
Main Responsibilities- Writing regulatory documents to support drug development, including SA, PIP, ODD, IMPD, and IB.
- Designing regulatory roadmaps and developing regulatory strategies for MAA submissions.
- Liaising with health authorities for drug development procedures and managing submissions through portals like CTIS and IRIS.
- Educational background in scientific or biomedical fields.
- A minimum of 8-10 years of experience in regulatory writing within the pharma sector or spin-offs/startups.
- Strong knowledge of regulatory affairs and advanced proficiency in IT tools, particularly MS Office Suite.
- Fluency in English (C1 or higher) is mandatory, with Spanish being a significant advantage.
- Home office and hybrid work model, allowing you to work from anywhere in Spain.
- Variety of projects, new challenges, and experiences to grow your career.
- Training and personal development programs to enhance your skills and well-being.
We offer a dynamic working environment with employees from over 15 nationalities, prioritizing physical, psychological, and emotional well-being. We are an equal opportunity employer with a seniority level of Associate and employment type of Full-time. Job function includes Consulting and Pharmaceutical Manufacturing.